Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
調査の概要
詳細な説明
This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups:
Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Joslin Diabetes Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
- A1C ≥7 %
- Consuming <3 servings of dairy products per day
- On stable dose of diabetes, blood pressure or cholesterol medications for 3 months
- Body weight is within 10% of current weight over the last 6 months before starting the study
Exclusion Criteria:
- Pregnancy or lactation
- Lactose intolerance
- Allergy to milk or any of its components
- Use of orlistat
- History of pancreatitis
- History of gastric bypass surgery or sleeve gastrectomy
- Active malignancy
- History of recent cardiovascular event
- Having a heart pacemaker
- Enrollment in other studies that may affect study outcomes
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Full fat dairy group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
|
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
|
|
実験的：Low fat dairy group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
|
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
|
|
他の：Control group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
|
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Hemoglobin A1C (A1C)
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in body weight
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in total cholesterol
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in high-density lipoprotein (HDL)
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in low-density lipoprotein (LDL)
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in triglycerides
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in fasting plasma glucose
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in body fat percentage
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in fat free mass
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Height in meters
時間枠：Baseline
|
Used in calculation of Body Mass Index
|
Baseline
|
|
Change in total body water
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in waist circumference
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in trunk fat percentage
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in visceral fat level
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in blood pressure
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in c-reactive protein level
時間枠：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Osama Hamdy, M.D., Ph.D.、Joslin Diabetes Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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